Replies to post #641445 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Some pharmaceutical companies may choose to submit their international regulatory applications for marketing approval in different jurisdictions consecutively for strategic reasons. This approach allows them to tailor their submissions and responses to each regulatory agency's specific requirements and feedback.

By submitting applications consecutively, companies can modify their submissions based on the feedback received from previous submissions, thereby potentially increasing the likelihood of approval. Additionally, it allows them to prioritize certain markets based on factors such as market size, patient population, (manufacturing readiness) and potential revenue.

However, it's important to note that this approach can lead to delays in accessing treatments for patients in some regions, as the approval process may take longer compared to simultaneous submissions.

Nevertheless, this strategy is often employed by companies to manage risks and optimize their chances of successful market entry in various regions. ChatGPT

[Poor Man -]

My concern with Project Orbis is the same as Horse’s. Working across different regulatory processes also runs the risk of slowing the approval process, especially since one RA issue could cause a knock on effect that causes the other RAs to slow down to consider the concerns of their peer RAs. More eyes might not be better.

Not clear to me that Project Orbis is actually more efficient. Someone will have to show the data.

The generic concerns, a few are moot to DCVax:

While Project Orbis offers several advantages, there are also some potential disadvantages to consider:

1. Limited scope: Project Orbis currently focuses on cancer drugs only. This means that drugs for other diseases or conditions may not benefit from the streamlined review process and patients may still face delays in accessing these treatments.

2. Varying regulatory requirements: Despite the collaboration among regulatory authorities, there may still be differences in the specific requirements and standards of each country. This can lead to challenges in aligning and harmonizing the review process, potentially causing delays or additional regulatory hurdles.

3. Resource constraints: Participating regulatory authorities may face resource constraints, including limited staff and expertise, which could impact the efficiency and speed of the review process. This could potentially result in delays in drug approvals.

4. Limited participation: While Project Orbis aims to involve multiple regulatory authorities, not all countries may choose to participate. This could limit the reach and impact of the initiative, particularly for patients in countries not involved in the collaboration.

5. Potential safety concerns: The expedited review process may result in a shorter timeframe for evaluating safety and efficacy data. While regulatory authorities strive to ensure patient safety, there is a risk that some safety concerns may not be fully identified or addressed during the accelerated review process.

It is important to note that these disadvantages are not unique to Project Orbis but are inherent challenges in any global regulatory collaboration initiative.

[pqr]

ATL and flipper thank you. Pretty much as I had understood but more color.